FDA Launches New Quality/Compliance Web Content

FDA's Office of Compliance and Biologics Quality (QCBQ) within the Center for Biologics Evaluation and Research (CBER) has launched a web page describing responsibilities such as inspection, surveillance, and compliance to pre- and post- market approval activities.

PPTA News

International Plasma Awareness Week 2021: Donate Plasma. Save Lives. +

ANNAPOLIS, MD (October 4, 2021) — The Plasma Protein Therapeutics Association (PPTA) is proud to mark the launch of the ninth annual International Plasma Awareness Week (IPAW), which will run from Monday, October 4 until Friday, October 8. Nearly 125,000 people in the U.S. with rare diseases, and countless others facing trauma and emergency medical needs every day, rely on medicines that are only available because of the commitment of dedicated plasma donors. Considering the nearly 20% decline in plasma donations seen last year due to the ongoing pandemic, the need for plasma donors is now more urgent than ever before.
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Calling on EU Policymakers to Increase Plasma Donations +

Brussels, (October 4, 2021) — The Plasma Protein Therapeutics Association (PPTA) is marking the 9th annual International Plasma Awareness Week (IPAW), October 4-8, by increasing awareness and understanding about the importance of plasma, particularly the urgent need to increase plasma donations in the European Union, while also recognizing and thanking plasma donors who save and improve the lives of patients who rely on plasma for their therapies. Considering the revision of the European blood and tissues and cells legislation, PPTA calls on policymakers and regulators throughout Europe to strengthen its legal framework to benefit plasma donations for plasma-derived medicines and encourage new approaches that increase the collection of plasma across the European Union.
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Plasma donations remain disappointingly low through ongoing pandemic, risking patients’ lives +

The Plasma Protein Therapeutics Association (PPTA) is aware of emerging reports regarding patients not having reliable access to lifesaving plasma-derived therapies used to treat a variety of serious, rare, and chronic conditions caused by missing or deficient proteins in their blood. While there could be many reasons for these access challenges, the fact remains that for most of these conditions, plasma is the only starting material for effective therapies. As such, PPTA repeats its calls for all healthy adults to donate plasma at one of the more than 1,100 donation centers throughout the United States and in four European countries. Additionally, considering the European Union relies on plasma from the U.S. for approximately 30% of its plasma-derived therapies, PPTA continues to advocate for policies that encourage more donation opportunities throughout the EU.
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PPTA Responds to ProPublica Article +

An article published by ProPublica on June 24 (“The U.S. Is Closing a Loophole That Lured Mexicans Over the Border to Donate Blood Plasma for Cash”) is the latest sensationalized reporting from ProPublica and ARD German TV reporters who continue to misrepresent and malign U.S. policies regarding plasma donation as well as the scores of committed individuals who cross the U.S.-Mexico border to donate their plasma. Tens of thousands of people safely donate their plasma every day in the U.S., with every donation directly contributing to helping nearly 125,000 Americans with serious and often life-threatening conditions live healthy and normal lives, as well as countless others facing trauma and emergency medical needs every day.
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The Source, the international magazine of the plasma protein therapeutics industry, is published three times a year.

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"How Is Your Day?" is an initiative to raise awareness of the unique nature of plasma protein therapies and the value they provide to patients. It aims to inform and educate decision makers and the general public worldwide.

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FDA Launches New Quality/Compliance Web Content

International Plasma Awareness Week 2021: Donate Plasma. Save Lives. +

Calling on EU Policymakers to Increase Plasma Donations +

Plasma donations remain disappointingly low through ongoing pandemic, risking patients’ lives +

PPTA Responds to ProPublica Article +

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